Global Regulatory Affairs Manager, Oncology

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Global Regulatory Affairs Manager, Oncology

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

As a Global Regulatory Affairs Manager at GSK, you will develop and execute global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance with internal and external requirements. You will be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head and collaborate with cross-functional teams to shape development plans and regulatory interactions across multiple regions. We value clear thinking, collaboration, practical problem solving and a patient-first mindset.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.  These responsibilities include some of the following:

• Work closely with GRL, global/regional counterparts and local operating companies to develop and deliver robust regulatory strategies that meet key market requirements
• Collaborate with cross-functional teams to align regulatory plans with Medicines Development Strategy and Integrated Asset Plan
• Support interactions, reviews, and submissions with regional/local regulatory authorities for product development and approval
• Assess regulatory intelligence, precedents and competitive landscape to inform strategy development and improve decision-making
• Ensure compliance with global, regional, and local regulatory requirements throughout the product lifecycle
• Drive process improvement, innovation, and performance excellence through the development and implementation of strategic changes

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Minimum: Bachelor’s degree in biological, pharmaceutical or healthcare science
• 1+ year of experience in drug development process, preferably in regulatory affairs and oncology

Preferred Qualifications:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Advanced scientific degree (PhD, MD, PharmD)
• Knowledge of clinical trial and licensing requirements in at least one major regional/global market
• Proven ability in managing global and regional development, submission, and approval activities
• Demonstrated ability to foster collaborative environments, proactively resolve challenges, and develop innovative solutions within regulatory constraints
• Proficiency in digital fluency tools to enhance project delivery, efficiency, and innovation
• Strong written and verbal communication skills for clarity and impact
• Experience working effectively in matrix teams
• Experience working in oncology

#LI-GSK

Skills

Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Regulatory Strategies, Resource Management, Stakeholder Management

 

 

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $138,750 to $231,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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